Avasopasem治疗放疗诱导的严重口腔粘膜炎,III期ROMAN试验未达到主要终点

2021-10-20 Allan MedSci原创

Avasopasem是一种选择性小分子歧化酶模拟物,正在开发用于减少局部晚期头颈癌 (HNC) 患者的辐射诱导的严重口腔粘膜炎 (SOM) 。

口腔粘膜炎是放射治疗的副作用,其特征是剧烈的疼痛、炎症、溃疡和口腔出血。对于头颈癌患者,放疗是主要的治疗方法。接受放射治疗的头颈癌患者中,约有70%会出现严重的口腔粘膜炎 (SOM),其定义为无法进食固体食物(3级)或饮用液体(4 级)。SOM对患者的影响是巨大的,特别是当需要住院和/或手术放置PEG管以维持营养和水合作用时。SOM会导致放疗中断,从而对癌症治疗结果产生不利影响,这可能会影响其中许多患者对肿瘤控制的良好预后。目前还没有批准用于预防或治疗SOM的药物。

Galera Therapeutics是一家临床阶段的生物制药公司,今天公布了avasopasem III期ROMAN试验的结果,该试验评估了avasopasem治疗接受标准放射治疗的局部晚期头颈癌 (HNC) 患者的严重口腔粘膜炎 (SOM),但该试验未达到降低SOM发生率的主要终点。

Avasopasem是一种选择性小分子歧化酶模拟物,正在开发用于减少局部晚期头颈癌 (HNC) 患者的辐射诱导的严重口腔粘膜炎 (SOM) 。FDA先前已授予avasopasem快速通道和突破性疗法称号,用于减少放疗诱导的SOM。

OMAN试验的主要发现包括:

  • avasopasem治疗组 (54%) 与安慰剂组 (64%) 相比,SOM 的发生率相对降低 16% (p=0.113)(主要终点)
  • avasopasem治疗组(8 天)与安慰剂组(18 天)相比,SOM天数相对减少56%(p=0.011)(次要终点)
  • avasopasem治疗组 (24%) 与安慰剂组 (33%) 相比,SOM的严重程度(4 级OM的发生率)相对降低 27%(p=0.167)(次要终点)
  • Avasopasem总体耐受性良好,在活性药物组和安慰剂组中不良事件发生率相似

 

原始出处:

https://www.firstwordpharma.com/node/1872435?tsid=4

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    2022-09-19 neizongke
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    2022-04-11 huangdf
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    2022-01-15 guoyibin
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    2021-11-29 juliusluan78
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    2021-10-21 liucl1027

    希望没有更好的药物

    0

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    2021-10-21 呼吸科小医生

    学习了很多谢谢

    0

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研究认为,在接受头颈部放射治疗的患者中,多塞平漱口液或苯海拉明利多卡因抗酸漱口液可减少患者口腔粘膜炎疼痛,但与安慰剂相比,效果不显著

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日本Solasia Pharma KK公司宣布其episil口服液已获得国家食品药品监督管理局(NMPA)的批准,用于缓解化疗/或放疗引起的口腔粘膜炎(OM)。作为缓解口腔粘膜炎的唯一即用型医疗设备,episil将为国内口腔粘膜炎患者提供新的治疗选择,特别是对于接受放疗/或化疗后的癌症患者。

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